Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes.
This muti-center, prospective observational study aims to construct a prospective cohort database for perioperative cardiac surgery. We plan to enroll adult patients who undergo cardiac surgery with cardiopulmonary bypass at the Second Affiliated Hospital of Zhejiang University and other hospitals from May 1, 2026 to December 31, 2031. Multi-dimensional perioperative data, including laboratory tests, hemodynamics, intraoperative echocardiography, and perioperative medications, will be collected and integrated, along with epidemiological data, clinical diagnosis and treatment information, multimodal data, and follow-up outcomes. An interconnected big data sharing platform will also be built.
This database will provide a valuable resource for multi-level researches such as perioperative risk assessment, individualized prevention, precise diagnosis and treatment, and therapeutic efficacy monitoring. It will also help optimize surgical and perioperative management, improve the quality of cardiac surgery, and provide evidence for the refinement of China's healthcare system, ultimately enhancing perioperative safety and rehabilitation efficiency of patients.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Min Yan, Doctor
- Número de telefone: 15888210247
- E-mail: zryanmin@zju.edu.cn
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China
- Recrutamento
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Exclusion Criteria:
- Refusal to provide informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Perioperative Observation Group
Patients undergoing cardiac surgery with cardiopulmonary bypass during the perioperative period (including, but not limited to, valve surgery, coronary artery bypass grafting, and combined procedures that require cardiopulmonary bypass)
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Cardiac surgey
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Prazo: 4, 12 weeks and 1years after surgery
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Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
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4, 12 weeks and 1years after surgery
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Incidence of Perioperative Transfusion of Allogeneic Blood Products
Prazo: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Prazo: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidência de readmissão hospitalar não planeada dentro de 4 e 12 semanas após a cirurgia
Prazo: 4 e 12 semanas após a cirurgia
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Readmissão hospitalar não planeada
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4 e 12 semanas após a cirurgia
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Incidence of perioperative myocardial infarction
Prazo: 4, 12 weeks and 1years after surgery
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Myocardial infarction
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4, 12 weeks and 1years after surgery
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Incidence of New-onset stroke
Prazo: 4, 12 weeks and 1years after surgery
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New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
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4, 12 weeks and 1years after surgery
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Incidence of death
Prazo: 4, 12 weeks and 1years after surgery
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death
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4, 12 weeks and 1years after surgery
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Incidence of acute kidney injury
Prazo: 7days after suegery
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acute kidney injury was defined by guidelines of kindey disease：improving global outcomes（KIDGO）
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7days after suegery
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Incidence of infectious complications
Prazo: 4, 12 weeks and 1years after surgery
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Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
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4, 12 weeks and 1years after surgery
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Length of hospital stay
Prazo: Through patients discharge, an average of 7 days after surgery
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Length of hospital stay
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Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
Prazo: Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
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Through patients discharge, an average of 7 days after surgery
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Quality of life scores
Prazo: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status. |
at 4, 12 weeks and 1 years after surgery
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Quality of life scores
Prazo: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life. |
at 4, 12 weeks and 1 years after surgery
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-0345
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